胰岛素生产工艺及车间设计  

Process and facility design of insulin

作　　者：王小明 程翔 Wang Xiaoming;Cheng Xiang(SINO PHARMENGIN CORPORATION,Wuhan,Hubei 430077,China)

机构地区：[1]中国医药集团联合工程有限公司,武汉430077

出　　处：《化工与医药工程》2024年第1期58-63,共6页Chemical and Pharmaceutical Engineering

摘　　要：在药品生产车间的设计过程中,对产品及其工艺的正确理解至关重要。特定工艺所需要的条件对设备的布置、乃至整个车间的布局都有很大的影响。文章简述了胰岛素产品的发展历史,对现行主流产品的生产工艺和车间设计做了一般性介绍,针对胰岛素原料药产品纯化工艺复杂、甲类试剂用量大的特点,采用实际项目案例进行解释,阐述了胰岛素生产车间的设计方法。It is essential to understand the product and process correctly in the design of a drug workshop.The conditions needed for a particular process significantly affect the equipment layout and,therefore,the overall facility layout.This article describes the development history of insulin products briefly,and generally introduces the process and facility design of current mainstream products.In view of the complex purification process and large dosage of class A reagent used,an actual project was used to explain and elaborate the design methods of an insulin API workshop.

关 键 词：重组人胰岛素 表达系统 发酵 工艺 纯化 设计 

分 类 号：R392[医药卫生—免疫学]